Audited Supplier
TOP1 Laparoscopic Trocar china Manufacturer, 20years medical devices manufacturing expertise ,trustable and reliable.
G T.K trocars have been exported to 40 countries, most of which are European and American countries, such as the USA, UK, France, Germany, Italy, Belgium, Spain, Japan, South Korea.
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MDR CE FDA certificate laparoscopic disposable trocars for 3mm,5mm,10mm,12mm,15mm endoscopic surgery.
We adhere to strict quality control processes and systems and have been granted 700+ domestic and international patents, including 400+ authorized patents,with our products leading in the industry.
FDA 510K Approval
FDA 510K Letter: K193272
Trade/Device Name: GTK Trocars
Regulation Number: 21 CFR 876.1500
Date: July 6, 2020
CE certificate
Report No.: 17025753 014
Effective Date: July 24, 2020
| Trocars |
| Q: Are you a factory or trading company? |
| A: Yes. We are a factory in China with 20 years surgical devices developing and manufacturing experience. |
| Q: What is the core strength of GTK Medical? |
| A: Our core strength is strong R&D Capability (more than 600 patents applied) and world first class quality (FDA 510K, CE, ISO13485:2016) management on products. |
| Q: What makes GTK Trocars stand out? |
| A: Excellent sealing performance plus excellent smooth insertion and removal of surgical instruments. |
| Q: Do you provide free samples of GTK Trocars for clinical trial use? |
| A: Yes. We are proud and confident to provide free samples for real clinical testing and evaluation. |
| Q: Do you have exported experiences to large medical devices company/companies? |
| A: Yes. We exported to more than 40 countries, most of which are based in the America and Europe. |
| Q: Do you accept factory audit prior to formal partnership? |
| A: Yes. We are proud and confident to accept factory audit. We passed US FDA on site aduits on 2015 and 2021. |
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